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Syngene International, a leading global contract research, development and manufacturing organization (CDMO), has recently opened a new state-of-the-art sterile fill-finish facility at its Biocon Park campus in Bengaluru. This facility is equipped with the latest technologies and is designed to cater to the growing demand for cGMP manufacturing of sterile injectables in the biopharmaceutical industry.
The new facility is designed to process a wide range of liquid, lyophilization and nanoparticle formulations, including small molecules, biologics, and vaccines in fully automated operation, handling batch sizes ranging from a few hundred to several thousand vials and pre-filled syringes. The isolator-based filling line can process both liquid and lyophilized products in a variety of drug formulations including OEL Class 4 drugs.
As a sterile fill-finish facility, it offers multiple transfer system options (pressure or peristaltic pump) for highly sensitive biologics drug products. The advent of single-use disposable bags and an automated isolator-based filling line offers the added advantage of sterile operations with minimal manual interventions, thus providing a high level of sterility assurance. In addition, considering the impact of batch processing time on biopharmaceutical product stability, Syngene has adopted a ready-to-use format for sterile vials and pre-filled syringes, which can significantly reduce the batch processing time. This is specifically important for the fill-finish of clinical trial drug products.
"Adding fill-finish capabilities complements the recent drug substance expansions we have completed. This capability is also geared to meet the increasing demand for sterile injectables. The facility complies with the international regulatory standards for cGMP manufacturing expected by regulators said Dr. Mahesh Bhalgat, chief operating officer, Syngene International.
Given the critical nature of fill-finish in the pharmaceutical manufacturing process, Syngene International's state-of-the-art facility will go a long way towards eliminating inefficiencies and improving standardization and quality. For an industry in which these qualities are of the essence, the value of a streamlined manufacturing process cannot be underestimated, he added.
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